Macrophage PET/CT Imaging for the Diagnosis of Cardiac Sarcoidosis

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
SUMMARY

The purpose of the CuDOSIS study is to examine the diagnostic value of activated macrophage imaging in patients with or under evaluation for cardiac sarcoidosis. The PET/CT tracer 64Cu-DOTATATE is used as a tool to identify activated macrophages. The trial is an open-label prospective study. The study will include 54 participants from the Department of Cardiology and the Department of Clinical Physiology, Nuclear Medicine, and PET at Rigshospitalet. Further, the study will include data from 22 patients with NET who have been scanned with 64Cu-DOTATATE PET/CT previously as negative controls. Participants will be included in the following groups: Group A: 22 patients with clinically suspected cardiac sarcoidosis Group B: 22 patients with known cardiac sarcoidosis Group C: Up to 10 patients with clinically suspected or confirmed acute lymphocytic myocarditis Group D: 22 patients with NET without known inflammatory heart disease who have previously been scanned with 64Cu-DOTATATE PET/CT as part of their routine diagnostic work-up or follow-up (control group)

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age =\> 18 years

• Group A: 22 patients with clinically suspected cardiac sarcoidosis Group B: 22 patients with known cardiac sarcoidosis Group C: Up to 10 patients with clinically suspected or confirmed acute lymphocytic myocarditis Group D: 22 patients with NET without known inflammatory heart disease who have previously been scanned with 64Cu-DOTATATE PET/CT as part of their routine diagnostic work-up or follow-up (control group)

Locations
Other Locations
Denmark
Rigshospitalet
RECRUITING
Copenhagen
Contact Information
Primary
Finn Gustafsson, MD,PhD,DMSc
finn.gustafsson@regionh.dk
+45 35456340
Backup
Adelina Yafasova, MD
adelina.henney.yafasova@regionh.dk
+45 35456252
Time Frame
Start Date: 2023-11-01
Estimated Completion Date: 2027-01
Participants
Target number of participants: 76
Treatments
Group A
22 patients with clinically suspected cardiac sarcoidosis
Group B
22 patients with known cardiac sarcoidosis
Group C
Up to 10 patients with clinically suspected or confirmed acute lymphocytic myocarditis
Group D
22 patients with NET without known inflammatory heart disease who have previously been scanned with 64Cu-DOTATATE PET/CT as part of their routine diagnostic work-up or follow-up (control group)
Related Therapeutic Areas
Sponsors
Leads: Rigshospitalet, Denmark

This content was sourced from clinicaltrials.gov